Chinese Medicine Division

Arrangements upon the deadline of submission of test reports for transitional registration of proprietary Chinese medicine

The Chinese Medicines Board (CMB) of the Chinese Medicine Council of Hong Kong had issued a letter to Chinese Medicines Traders on 28th June 2006 regarding “Time for submission of product specification documents and general stability reports”. It had stated that proprietary Chinese medicines (pCm) eligible for transitional registration would be divided into two categories and have to submit the required documents to CMB, including product specification, certificate of analysis and general stability reports for the first batch of product before 30th June 2009 (ie. within 5 years from the deadline of application for transitional registration of pCm ) and before 30th June 2013 respectively according to its category.

Having regard to the situation of the trade, the CMB resolved in June 2013 to extend the deadline for holders of "Notice of confirmation of transitional registration of pCm" to submit product specification, method and certificate of analysis and general stability test report of the pCm from 30 June 2013 to 30 June 2015. For details, please refer to the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 26 June 2013 (Chinese version only). In addition, the CMB has formulated a set of arrangements regarding the processing of transitional registration of pCm to formal registration so as to expedite the processing. For details, please refer to the pCm to formal registration (Chinese version only) and the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 19 May 2014 (Chinese version only).

Having considered the latest situation of submission of reports by the trade, the CMB has decided to maintain the deadline of the submission of product specification, method and certificate of analysis and general stability test report. Holders of "Notice of confirmation of transitional registration of pCm" should submit the above test reports for their pCm on or before 30 June 2015.

In addition, in order to safeguard public health and to avoid delaying the progress of assessment of the application for registration of pCm by the CMB, if holders of "Notice of confirmation of transitional registration of pCm" cannot submit quality documents of their pCm according to the above arrangements, the CMB will consider refusing the application at an appropriate time. For details, please refer to the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 13 May 2015 (Chinese version only).